HypersomniaNCT05627388
Feasibility Study of At-Home EEG Monitoring for Hypersomnia
A study testing Dreem 3 System At-Home Monitoring in people with Hypersomnia and Narcolepsy, run by Kaiser Permanente.
Trial summary
The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypersomnia, Narcolepsy
- What is being tested?
- Dreem 3 System At-Home Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients must be a Kaiser Permanente member
- Patients must be ≥ 6 years old.
- Patients must have an indication for Multiple Sleep Latency Test for a diagnosis of hypersomnia
- Patients are able/willing to consent and willing to undergo the electrophysiological routine assessments described in the protocol
- Patients do not meet any exclusion criteria
Who cannot join
- Patients under 6 years old.
- If a patient is taking a wake promoting medication and is unsafe to withdraw the medication during the 2 weeks prior to the in-lab Polysomnography/Multiple Sleep Latency study
- Patients suffering from mental and/or physical disorders that could interfere with the study protocol or the interpretation of the results (exclusion based on clinical judgment)
- Shift workers or patients working unusual hours will be excluded
- Patients not able to sign an informed consent form
About this study
Official title: Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia
The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.
Read the detailed description
This clinical study is a prospective, single group assessment which will enroll patients who are prescribed a multiple sleep latency test (MSLT) at the Fontana Medical Sleep Center. Patients will be mailed an actigraph and a Dreem 3 system to undergo the following assessments:
- 1 initial in-person sleep physician encounter to discuss your sleep symptoms and review the informed consent form
- 1 week of actigraphy and Dreem 3 System monitoring. Actigraphy will be continuously monitored for 1 week to log sleep and wake periods. Dreem 3 System will be monitored for the first 5 nights and the last 2 days will be 48-hour continuous monitoring (i.e., day and night). Additionally, we will ask you to log your sleep/wake activity in a sleep diary.
- 2 consecutive in-lab sleep studies within a 24-hour period
- A few reminder telephone calls for at-home monitoring
Patients will have a follow up encounter with a physician after their in-lab visit. If a diagnosis is confirmed and treatment is initiated, the patient will be asked if they want to pursue treatment follow-up for the study. Again, patient will wear the Dreem 3 System and the actigraph during 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48 hour measurement, patients will wear the Dreem 3 system and actigraph (i.e. monitoring day and night). This procedure will occur once treatment is initiated as well as 1 month and 3 months after treatment initiation.
Patients will be asked to complete various sleep and quality of life questionnaires throughout the duration of the study. Questionnaires should take approximately 10-15 minutes to complete.
- Conditions
- Hypersomnia, Narcolepsy
- Being tested
- Dreem 3 System At-Home Monitoring
- Keywords
- At-Home Sleep EEG-Based Monitoring, Dreem 3 System, Polysomnography (PSG), Multiple Sleep Latency Test (MSLT)
- Medical subject headings
- Disorders of Excessive Somnolence, Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dreem 3 System At-Home MonitoringOther
Patients will be asked to wear the Dreem 3 System and actigraphy devices at home. Research support staff will teach patients how set up the device beforehand. Patients will wear Dreem and actigraph for 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48hr measurement, patients will wear the Dreem and actigraph. The patient will be given 2 devices, as one device can record up to 24h of data continuously. Patients are not required to stay home during the 48hr testing period. However, patients will be instructed to refrain from participating in activities which may shift or require removal of Dreem. Patients who wish to remain home for the 48hr testing period should have adequate sustenance (i.e., groceries). Any caffeine and sleep medication intake will be logged by the patient in a sleep diary. If needed, patients will be given an off work order from work/school for the 48hr assessment.
| Study group | Role | What they receive |
|---|---|---|
| Dreem 3 System | Other | Not described Receives: Other: Dreem 3 System At-Home Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring sleep and wake events for the evaluation of hypersomnia disorders
Evaluating feasibility, quality, \& patient compliance of Dreem monitoring.
The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the monitoring capabilities of Dreem and actigraphy devices.
- Usability Questionnaires: means, standard deviations, frequencies, \& scores
- Number, type \& structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the initial evaluation of hypersomnia disorders by the physician
- Dreem compliance: median/mean hours of usage over 24 hrs
- % of Dreem records which pass the quality control criteria
Measured: 2 weeks
Performance of the automatic scoring of the Dreem 3 compared to the consensus of 5 certified sleep scorers realized on the polysomnography, during PSG and MSLT
- Epoch by Epoch sleep stage scoring will be analyzed by generating the 5x5 confusion matrix between Dreem automatic sleep scoring and the 5 sleep scorers' consensus rating.
- The stability and correlation of each sleep variable will be examined graphically and using intraclass correlation coefficients (ICC) with 95% confidence intervals (95% CI).
Measured: 2 days
Measuring Treatment Efficacy with At-home EEG Monitoring (Dreem 3 System)
Evaluating feasibility, quality, \& patient compliance of Dreem monitoring after treatment initiation,1 month \& 3 months.
The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the treatment efficacy with the Dreem device.
- Clinical \& QoL PRO: Mean change from baseline in ESS/NSS/IHSS/FOSQ10/EQ5D5L
- Usability Questionnaires: means, standard deviations, frequencies, \& scores
- Number, type \& structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the treatment efficacy evaluation of hypersomnia by the physician
- Dreem compliance: median/mean hours of usage over 24 hrs
- % of Dreem records which pass the quality control criteria
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study startFeb 2023 (estimated)
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: Study was never started. The research protocol was redeveloped and submitted as a new study therefore we would like to close this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersomniaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Dreem SAS
- Responsible party
- Principal investigator, Dennis Hwang, MD, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627388
- Sponsor's protocol ID
- Dreem
- Status last verified
- May 2024
- First submitted
- 2 Sep 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia
- ClinicalTrials.gov ID
- NCT05627388
- Acronym / sponsor ID
- Dreem
- Conditions
- Hypersomnia, Narcolepsy
- Keywords
- At-Home Sleep EEG-Based Monitoring, Dreem 3 System, Polysomnography (PSG), Multiple Sleep Latency Test (MSLT)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started. The research protocol was redeveloped and submitted as a new study therefore we would like to close this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Dreem SAS
- Study start
- Feb 2023 (estimated)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.
Detailed description
This clinical study is a prospective, single group assessment which will enroll patients who are prescribed a multiple sleep latency test (MSLT) at the Fontana Medical Sleep Center. Patients will be mailed an actigraph and a Dreem 3 system to undergo the following assessments:
- 1 initial in-person sleep physician encounter to discuss your sleep symptoms and review the informed consent form
- 1 week of actigraphy and Dreem 3 System monitoring. Actigraphy will be continuously monitored for 1 week to log sleep and wake periods. Dreem 3 System will be monitored for the first 5 nights and the last 2 days will be 48-hour continuous monitoring (i.e., day and night). Additionally, we will ask you to log your sleep/wake activity in a sleep diary.
- 2 consecutive in-lab sleep studies within a 24-hour period
- A few reminder telephone calls for at-home monitoring
Patients will have a follow up encounter with a physician after their in-lab visit. If a diagnosis is confirmed and treatment is initiated, the patient will be asked if they want to pursue treatment follow-up for the study. Again, patient will wear the Dreem 3 System and the actigraph during 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48 hour measurement, patients will wear the Dreem 3 system and actigraph (i.e. monitoring day and night). This procedure will occur once treatment is initiated as well as 1 month and 3 months after treatment initiation.
Patients will be asked to complete various sleep and quality of life questionnaires throughout the duration of the study. Questionnaires should take approximately 10-15 minutes to complete.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dreem 3 System | Other | Other: Dreem 3 System At-Home Monitoring |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be a Kaiser Permanente member
- Patients must be ≥ 6 years old.
- Patients must have an indication for Multiple Sleep Latency Test for a diagnosis of hypersomnia
- Patients are able/willing to consent and willing to undergo the electrophysiological routine assessments described in the protocol
- Patients do not meet any exclusion criteria
Key exclusion criteria (5 listed)
- Patients under 6 years old.
- If a patient is taking a wake promoting medication and is unsafe to withdraw the medication during the 2 weeks prior to the in-lab Polysomnography/Multiple Sleep Latency study
- Patients suffering from mental and/or physical disorders that could interfere with the study protocol or the interpretation of the results (exclusion based on clinical judgment)
- Shift workers or patients working unusual hours will be excluded
- Patients not able to sign an informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dreem 3 System At-Home MonitoringPatients will be asked to wear the Dreem 3 System and actigraphy devices at home. Research support staff will teach patients how set up the device beforehand. Patients will wear Dreem and actigraph for 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48hr measurement, patients will wear the Dreem and actigraph. The patient will be given 2 devices, as one device can record up to 24h of data continuously. Patients are not required to stay home during the 48hr testing period. However, patients will be instructed to refrain from participating in activities which may shift or require removal of Dreem. Patients who wish to remain home for the 48hr testing period should have adequate sustenance (i.e., groceries). Any caffeine and sleep medication intake will be logged by the patient in a sleep diary. If needed, patients will be given an off work order from work/school for the 48hr assessment. | Other | Dreem 3 System |
Primary outcome
Measuring sleep and wake events for the evaluation of hypersomnia disorders
Time frame: 2 weeks
Evaluating feasibility, quality, \& patient compliance of Dreem monitoring. The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the monitoring capabilities of Dreem and actigraphy devices. * Usability Questionnaires: means, standard deviations, frequencies, \& scores * Number, type \& structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the initial evaluation of hypersomnia disorders by the physician * Dreem compliance: median/mean hours of usage over 24 hrs * % of Dreem records which pass the quality control criteria
Performance of the automatic scoring of the Dreem 3 compared to the consensus of 5 certified sleep scorers realized on the polysomnography, during PSG and MSLT
Time frame: 2 days
* Epoch by Epoch sleep stage scoring will be analyzed by generating the 5x5 confusion matrix between Dreem automatic sleep scoring and the 5 sleep scorers' consensus rating. * The stability and correlation of each sleep variable will be examined graphically and using intraclass correlation coefficients (ICC) with 95% confidence intervals (95% CI).
Measuring Treatment Efficacy with At-home EEG Monitoring (Dreem 3 System)
Time frame: 3 weeks
Evaluating feasibility, quality, \& patient compliance of Dreem monitoring after treatment initiation,1 month \& 3 months. The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the treatment efficacy with the Dreem device. * Clinical \& QoL PRO: Mean change from baseline in ESS/NSS/IHSS/FOSQ10/EQ5D5L * Usability Questionnaires: means, standard deviations, frequencies, \& scores * Number, type \& structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the treatment efficacy evaluation of hypersomnia by the physician * Dreem compliance: median/mean hours of usage over 24 hrs * % of Dreem records which pass the quality control criteria
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dreem 3 System At-Home Monitoring in people with Hypersomnia and Narcolepsy, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring sleep and wake events for the evaluation of hypersomnia disorders (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.